FDA Issues Draft Guidance on Digital Health Technologies in Clinical Trials

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Recent advancements in sensor technology and data transmission methods stand to benefit clinical trials by facilitating data collection through digital health technologies (DHTs). The U.S. Food and Drug Administration (FDA) defines a DHT as any system that uses computing platforms, connectivity, software or sensors for healthcare purposes. On Dec. 23, 2021, the FDA issued draft guidance to provide recommendations for clinical trial sponsors, investigators, sites and other interested parties on using DHTs to collect data remotely from clinical trial participants.

Executive Summary

  1. DHTs are an emerging tool for clinical trials that facilitate remote data collection.
  2. The FDA has issued draft guidance on the use of DHTs in clinical trials, including requirements for policies and procedures related to DHTs.
  3. Sponsors, sites, and investigators must carefully analyze whether DHTs fit the purpose of the clinical trial. This requires considering participant populations, DHT design and ease of operation, and possible use of personal devices (e.g., mobile phones) rather than investigator-provided devices.
  4. Sponsors, sites, and investigators must analyze DHTs for risks, including clinical risks associated with measurement error and cybersecurity threats, privacy-related risks and licensing agreements (when using personal devices) that could result in unwanted data sharing, and unique issues of informed consent.
  5. Sponsors, sites, and investigators can address risks related to the use of DHTs through proper record retention, training, and policies and procedures that address technical, safety, privacy, and clinical considerations.

Interested parties must submit comments and suggestions on the FDA’s draft guidance by Wednesday, March 23, 2022.

What Is a DHT?

DHTs are systems that use computing platforms, connectivity, software or sensors for healthcare purposes. This can include hardware, software or a combination of hardware and software. DHT hardware consists of sensor hardware that facilitates continuous or intermittent physiological or behavioral data recording. DHT software can provide and administer electronic clinical outcome assessments and reports. For example, a glucometer that collects and transmits data is a DHT.

Additionally, suppose that glucometer utilizes software that can be downloaded to participants’ mobile phones, on which the participants can rate their perceived functioning each day. In that case, that software is also a DHT. Multiple DHTs can be used at once in a clinical investigation to collect a range of helpful information from remote participants.

The value of DHTs is apparent compared to more traditional intermittent trial visits. Traditional modes of clinical data aggregation are hindered by the burden of traveling to the trial site for participants, especially for participants with physical or cognitive limitations, those with time constraints, or geographically dispersed participants. Remote data collection through DHTs allows for continuous or more frequent data collection from participants regardless of their location or capability. DHTs also allow for decentralized clinical trials with larger participant pools.

The following details the FDA’s proposed guidance on selecting DHTs and identification and management of risks.

Selection Considerations

Sponsors, investigators and sites should consider the following when selecting a DHT that is appropriately fit for a particular clinical investigation. The ability to validate DHT data must be sufficient to support its use and interpretability in the clinical investigation.

  1. Population. Consider whether the clinical trial populations’ education, language, age and technical aptitude affect reliable outcomes. For example, DHTs may require large text or buttons, translated versions or other changes to properly relate to the clinical trial’s population.
  2. Design and Operation. Consider the power needs, data storage, operational specifications, environmental factors and privacy and security requirements, which all factor into which DHT to use for a trial.
  3. Use of Personal Device or Trial Device. Consider whether familiar devices reduce certain burdens. In all cases, devices should be technologically aligned and provided to participants who do not already possess a qualifying device.

Identification of Risks

The FDA’s guidance highlights the following risks associated with DHT use in clinical trials that sponsors, investigators and sites should consider.

  1. Clinical Risks. Analyze DHTs for physical features that could cause injury to participants; risks of erroneous measurement, especially in situations where measurements provide feedback to modifications in the administration of investigated products (e.g., glucometers); and cybersecurity risks that may impact the functionality and safe data storage and transmission.
  2. Privacy Risks. Analyze DHTs for potential disclosure risks to protected health information and vulnerable points for malicious intervention and access. Additionally, determine whether general-purpose devices like mobile phones have end-user licensing agreements or terms of service that allow data sharing with manufacturers or other parties.
  3. Informed Consent. As with any clinical investigation, disclose to participants the risks associated with the trial. This is very important when introducing DHTs, which carry their own unique risks, to a trial. Investigators should explain to participants the information collected, steps taken to ensure privacy and security, any potential costs related to the DHT (e.g., data charges on mobile phones), and any issues related to end-user license agreements.

Management of Risks

The FDA proposed the following guidance to limit risks associated with the use of DHTs.

  1. Proper Record Retention. When using DHTs to record and transmit data, all data should be securely transferred to and retained in a durable electronic data repository. The FDA previously issued relevant guidance on this in Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers (June 2017).
  2. Training. All participants and trial personnel should be trained to use the selected DHTs before the trial begins. Training should cover all topics ranging from uploading data, connecting networks for transmission and responding to DHT errors.
  3. Policies and Contingency Plans. Ensure proper policy drafting and planning to protect against the threat of noncompliance with the FDA’s guidance. The following are key policies and plans sponsors and sites must establish before using DHTs in clinical trials:
    1. Policies and procedures for technical assistance.
    2. Policies and procedures to address potential technical, privacy and clinical issues.
    3. Policies and procedures for safety monitoring, specifically addressing abnormal measurements related to safety.
    4. Policies and procedures for record-keeping of DHT data.
    5. Policies and procedures to replace and repair hardware when malware is detected on a DHT.

The recent shift from analog to decentralized clinical trials will continue due to the ability of DHTs to exploit varied and continuous data collection. The FDA is the first of many agencies to appreciate the risks generated by such technology in clinical trials. Sponsors, investigators and sites must carefully consider all risks associated with the use of DHTs and develop policies around them.

As guidance from the FDA and other agencies changes the regulatory landscape, the authors of this article and the McGuireWoods digital health practice group are prepared to advise. Please contact the authors of this article for additional information on how this guidance, if finalized, will impact the performance of clinical trials, and what sponsors, investigators, and sites must do to prepare.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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